The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Porous Coated Total Hip Pros. Acetabular Component.
| Device ID | K895607 |
| 510k Number | K895607 |
| Device Name: | POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | William Petty |
| Correspondent | William Petty EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-11-17 |